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This is an open-label, balanced, randomized, two-period, crossover, single dose study to compare the relative bioavailability in normal healthy, adult, human subjects under Fed and Fasting conditions. Subjects will receive a single oral dose of probenecid oral suspension (100 mg/mL) under fed and fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PanCytoVirâ„¢ 1000 mg fasted | Experimental | Single oral dose of PanCytoVirâ„¢ 1000 mg (100 mg/mL suspension) following an overnight fast |
|
| PanCytoVirâ„¢ 1000 mg fed | Experimental | Single oral dose of PanCytoVirâ„¢ 1000 mg (100 mg/mL suspension) following a standard, high-fat, high-calorie breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PanCytoVirâ„¢ | Drug | PanCytoVirâ„¢ 100 mg/mL oral suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess food effect on PanCytoVirâ„¢ in healthy, adult, human subjects as assessed by Cmax | The drug concentration in plasma assessed by Cmax | 7 days |
| To assess food effect on PanCytoVirâ„¢ in healthy, adult, human subjects as assessed by AUC | The drug concentration in plasma assessed by AUC | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| the Incidence rates of AEs, TEAEs and Serious Adverse Events (SAEs) | Numbers and incidence rates of AEs, TEAEs and Serious Adverse Events (SAEs) will be tabulated using available version of Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT), system organ class (SOC), severity and relationship. A patient having the same AE will be counted only once in calculating frequency while patient having same AE with different start date then both will be considered for calculating frequency. If AE is with same start date but different criteria (severity, relationship to study medication and outcome), worst case/latest case (whichever applicable) will be considered. Incidence of AEs will be summarized with count (%). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Martin, PharmD | TrippBio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vayam Research Solutions Limited | Gujarat | India | India |
Plans are currently being developed
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| 7 days |